These articles have been accepted for publication in the British Journal of Dermatology and are currently being edited and typeset. Readers should note that articles published below have been fully refereed, but have not been through the copy-editing and proof correction process. WileyBlackwell and the British Association of Dermatologists cannot be held responsible for errors or consequences arising from the use of information contained in these articles; nor do the views and opinions expressed necessarily reflect those of Wiley-Blackwell or the British Association of Dermatologists This article is protected by copyright. All rights reserved. Received Date : 23-Jul-2014 Accepted Date : 07-Aug-2014 Article type
: Correspondence
Statin Therapy for Venous Ulcers Dear Editor, The recent paper by Evangelista et al.1 seems to offer the promise of an inexpensive, readily available, easy to administer, and highly efficacious, adjunctive therapy for the treatment of chronic venous leg ulcers. We congratulate the authors on this very provocative study in which subjects were randomized to receive simvastatin 40 mg qd, or a placebo pill, in addition to standard compression therapy. As with any surprisingly positive finding, the potential benefit of added simvastatin will require independent confirmation which should address some potentially important methodological issues. First, this was a small single-center trial. Regulatory agencies require multicenter trials for confirmation of efficacy to prevent unintentional or conscious bias, outlier outcomes, or other idiosyncratic site effects from significantly influencing overall results. A single-center study has none of these safeguards in place and can therefore only be considered exploratory. Second, it would be difficult to imagine more favorable outcomes than those achieved in this trial. The authors report healing rates at ten weeks of 67% for ulcers >20 cm2 (>5 cm in diameter), and 100% for ulcers ≤20 cm.2 This is in comparison to the placebo
This article is protected by copyright. All rights reserved. group where 0% and 50% achieved closure, respectively. These results are particularly surprising when one considers that these ulcers were not small, and not young; the mean size for ulcers that closed was 12 cm2 and 31 cm2 for placebo and simvastatin groups with average chronicity of 2.4 and 3.3 years, respectively. According to Margolis,2 a wound >10 cm2 and >12 months old has only a 22% chance of healing after 24 weeks of good therapy with compression. If one compares the outcomes achieved for the placebo group with those from other studies with a compression only group, it is apparent that the proportion healed is unusually high. Kirsner et al.3 reported 46% healed at 12 weeks for ulcers treated with 4-layer compression. Although this seems similar to the 50% reported for the smaller ulcers (≤20 cm2) in the Evangelista study, these ulcers were all
: Correspondence
Statin Therapy for Venous Ulcers Dear Editor, The recent paper by Evangelista et al.1 seems to offer the promise of an inexpensive, readily available, easy to administer, and highly efficacious, adjunctive therapy for the treatment of chronic venous leg ulcers. We congratulate the authors on this very provocative study in which subjects were randomized to receive simvastatin 40 mg qd, or a placebo pill, in addition to standard compression therapy. As with any surprisingly positive finding, the potential benefit of added simvastatin will require independent confirmation which should address some potentially important methodological issues. First, this was a small single-center trial. Regulatory agencies require multicenter trials for confirmation of efficacy to prevent unintentional or conscious bias, outlier outcomes, or other idiosyncratic site effects from significantly influencing overall results. A single-center study has none of these safeguards in place and can therefore only be considered exploratory. Second, it would be difficult to imagine more favorable outcomes than those achieved in this trial. The authors report healing rates at ten weeks of 67% for ulcers >20 cm2 (>5 cm in diameter), and 100% for ulcers ≤20 cm.2 This is in comparison to the placebo
This article is protected by copyright. All rights reserved. group where 0% and 50% achieved closure, respectively. These results are particularly surprising when one considers that these ulcers were not small, and not young; the mean size for ulcers that closed was 12 cm2 and 31 cm2 for placebo and simvastatin groups with average chronicity of 2.4 and 3.3 years, respectively. According to Margolis,2 a wound >10 cm2 and >12 months old has only a 22% chance of healing after 24 weeks of good therapy with compression. If one compares the outcomes achieved for the placebo group with those from other studies with a compression only group, it is apparent that the proportion healed is unusually high. Kirsner et al.3 reported 46% healed at 12 weeks for ulcers treated with 4-layer compression. Although this seems similar to the 50% reported for the smaller ulcers (≤20 cm2) in the Evangelista study, these ulcers were all
